MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 32MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-32
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Unspecified Musculoskeletal problem (4535); Aseptic loosening (4883)
Date of Event	06/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 02-012-35-4009 - logic tibia ps mod insrt sz 4 9mm: sn# (b)(6).02-010-01-0340 - logic femoral ps cem right sz 4: sn# (b)(6).02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t: sn# (b)(6).1500-s - cemex system 80g: sn# (b)(6).H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2022-01394, 1038671-2026-00371.The reason for the revision may have been the result of prosthesis wear and loosening as reported.However, the reported prosthesis wear and potential contributions of implant positioning and/or patient-related conditions to the sequence of events cannot be confirmed as the devices were not available for evaluation and limited information was provided at the time of evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial total knee replacement on the right side.Subsequently, the patient experienced tibial and patellar polyethylene wear.Femoral loosening, osteolysis and synovitis.As a result, approximately four years post-surgery, the patient underwent a revision.Patient was last known to be in stable condition following the event.The patient continues to be limited in his activities of daily living, following the revision surgery.No additional information is available.This is report 3 of 3 for this event/patient.

• Brand Name: THREE PEG PATELLA 32MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24780653
• Report Number: 1038671-2026-00372
• Device Sequence Number: 15936543
• Product Code: JWH
• UDI-Device Identifier: 10885862039590
• UDI-Public: 10885862039590
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/17/2019
• Device Catalogue Number: 200-02-32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 04/03/2026
• Date Device Manufactured: 04/22/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male